The Innovative Medicines Initiative (IMI) is launching the first eight projects of its Ebola+ programme, to accelerate all aspects of vaccine development and manufacturing as well as deployment and compliance with vaccine regimens and diagnostics. The announcement comes in the run up to the World Economic Forum in Davos, where Ebola will feature high on the agenda.
8 000 people dead
The Ebola+ programme was created in response to the ongoing Ebola outbreak in western Africa, which has killed over 8 000 people so far. Between them, the projects bring together over 40 partners from the pharmaceutical & diagnostics industries, public health bodies, academia, aid organisations, and small biotech companies in Europe, Africa and the United States.
Total budget €215 million
Previous experience at IMI has shown that consortia of this kind, bringing together diverse groups from around the world, can make progress in even the most challenging disease areas.
The projects will have a total budget of €215 million, part of which comes from Horizon 2020, the EU’s research and innovation programme, and part of which comes in the form of in-kind contributions from the European Federation of Pharmaceutical Industries and Associations (EFPIA) partners in the projects.
Promising vaccine candidate
One of the project´s work packages is co-lead by Ali Harandi, researcher at the Sahlgrenska Academy, Univiersity of Gothenburg. The project focuses on a vaccine candidate named ‘vesicular stomatitis virus-vectored Zaire Ebola vaccine´, VSV-ZEBOV.
“The World Health Organization has identified VSV-ZEBOV as one of the three most promising Ebola vaccine candidates, and clinical trials are already underway in Europe and Africa. Our project builds on this existing asset to advance the development of VSV-ZEBOV”, says Ali Harandi:
“The EU-IMI investment enables us to harness the power of the cutting edge omics technologies along with the state-of-the-art immunological read outs to carry out systems analysis of human innate and adaptive immune responses to VSV-ZEBOV vaccination. This will allow us to gather vital information on both the strength and quality of the immune responses triggered by the vaccine as well as vaccine safety”.
Irene Norstedt, IMI Acting Executive Director, said: ‘The launch of these exciting new projects demonstrates the ability of the Innovative Medicines Initiative to respond rapidly to emerging healthcare emergencies with a programme that will tackle a range of challenges in Ebola research while complementing work supported by other organisations. Our hope is that these projects will help to make a difference in both the current and future outbreaks.’
Step up the efforts
European Commissioner for Research, Science and Innovation Carlos Moedas said: ‘There is no vaccine or treatment against Ebola as yet, so we must urgently step up our efforts in Ebola research. With this funding from Horizon 2020 and our industry partners, we are speeding up the development of an Ebola vaccine as well as rapid diagnostic tests to aid heroic health workers. These are the tools we need to defeat Ebola once and for all.’
Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Richard Bergstrom said: ‘The discussions on Ebola set to take place in Davos demonstrate the need to find new ways to deal with such global health crises. The Innovative Medicines Initiative, with its ability to mobilise various public and private partners, offers one solution. Thanks to its collaborative spirit, IMI’s Ebola+ programme allows us to work towards solutions efficiently, in a way that no single body could alone.’
At least 21 000 cases
The current Ebola epidemic is unprecedented in its scale and geographical distribution. According to reports from the WHO, as of 11 January there have been over 21 000 confirmed, probable, and suspected cases of EVD in the current outbreak and over 8 000 deaths, most of them in Guinea, Liberia, and Sierra Leone.
WHO factsheet on Ebola: http://www.who.int/mediacentre/factsheets/fs103/en/
WHO statistics on the current outbreak: http://www.who.int/csr/disease/ebola/situation-reports/en/
WHO factsheet on Marburg heamorrhagic fever: http://www.who.int/mediacentre/factsheets/fs_marburg/en/
Ali Harandi, researcher at the Sahlgrenska Academy, University of Gothenburg
Innovative Medicines Initiative
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ABOUT EBOLA AND RELATED DISEASES
Ebola virus disease (EVD), previously known as Ebola haemorrhagic fever, is a rare and deadly disease caused by infection with one of the Ebola virus strains. The virus spreads in the human population through direct human-to-human contact with the bodily fluids of infected patients who are showing symptoms.
It has an incubation period of 2-21 days, and it usually begins with flu-like symptoms, but rapidly progresses to multiple organ failure and blood-clotting abnormalities which manifest as internal and external haemorrhages (bleeding). It is fatal in between 25% and 90% of cases. There is currently no licensed treatment against EVD, and the development of treatments and preventive measures such as vaccines is hampered by challenges including manufacturing-related hurdles, the stability of vaccines during transport and storage, vaccine deployment, and the time taken to diagnose cases of EVD.
Ebola is a member of the filovirus family of viruses, which also includes Marburg virus, and the IMI Ebola+ programme is also designed to address these. Like Ebola, Marburg causes cause severe, often fatal haemorrhagic fever in humans and other primates (monkeys, gorillas and chimpanzees), and like Ebola, it is transmitted directly from one person to another. (In contrast, other viruses that cause haemorrhagic fevers are spread via intermediate hosts – for example, dengue fever is transmitted by mosquitoes.) There is no specific treatment or vaccine against Marburg heamorrhagic fever.
Development of Ebola vaccines – 3 projects – There are currently no licensed vaccines for Ebola. However, there are a number of vaccine candidates in development, and three projects in the new IMI Ebola+ programme will generate the data needed to assess the safety and immunogenicity of different vaccine candidates and the level and duration of protection they actually offer against the disease.
Scaling up vaccine manufacture – 1 project – Ebola vaccines can only be manufactured in facilities with an appropriate biosafety rating. Relatively few manufacturers have the biosafety rating required for the manufacture of Ebola vaccines, and this is slowing down the production of vaccine candidates. This project will establish a platform capable of rapidly producing sufficient quantities of the vaccine, while adhering to stringent quality and safety requirements. In parallel, this project will create additional vaccine production capacity to allow for the rapid preparation of large quantities of vaccines.
Compliance with vaccine regimens – 1 project– For a vaccine to have a real impact on an outbreak, high levels of vaccination coverage are essential. In addition, for lasting protection, two doses of the vaccine may be needed. However, the stigma surrounding Ebola, coupled with a suspicion of vaccines in general, could deter many people from getting vaccinated. This project will investigate innovative ways of promoting compliance, for example by using mobile phones. The project will also use these technologies to raise awareness and acceptance of vaccination campaigns.
Rapid diagnostic tests – 3 projects– There is an urgent need for fast, reliable tests to determine if someone is infected with Ebola or not. Three projects will pave the way for rapid diagnostic tests capable of delivering reliable results at the point of care in as little as 15 minutes.
BY: KRISTER SVAHN
031 786 38 69
Originally published on: sahlgrenska.gu.se